NAVI Amazon Propol by EQ Maxon Corp.

NAVI Amazon Propol by

Drug Labeling and Warnings

NAVI Amazon Propol by is a Otc medication manufactured, distributed, or labeled by EQ Maxon Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NAVI AMAZON PROPOL- sodium monofluorophosphate silicon dioxide paste 
EQMAXON Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active Ingredients: Silicon Dioxide 16%, Sodium Monofluorophosphate 0.19%

PURPOSE

Purpose: Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years old

INDICATIONS & USAGE

- Supervise children as necessary until being capable of using without supervision

- Instruct children under 6 years old in good brushing and rinsing habits

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Inactive Ingredients: Propolis Extracts, Silica, Chitosan, Sorbitol Solution, Licorice Extracts, Xylitol

DOSAGE & ADMINISTRATION

- Brush teeth twice daily or after each meal as directed by a dentist or doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

NAVI AMAZON PROPOL 
sodium monofluorophosphate silicon dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55526-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.228 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) 3.6 g  in 120 g
GLYCERIN (UNII: PDC6A3C0OX) 6 g  in 120 g
ERYTHRITOL (UNII: RA96B954X6) 0.12 g  in 120 g
XYLITOL (UNII: VCQ006KQ1E) 0.24 g  in 120 g
STEVIOL (UNII: 4741LYX6RT) 0.24 g  in 120 g
CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64) 0.12 g  in 120 g
LICORICE (UNII: 61ZBX54883) 0.12 g  in 120 g
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.12 g  in 120 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55526-0001-1120 g in 1 TUBE; Type 0: Not a Combination Product01/01/201311/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/201311/01/2019
Labeler - EQMAXON Corp. (557821534)
Registrant - EQMAXON Corp. (557821534)
Establishment
NameAddressID/FEIBusiness Operations
EQMAXON Corp.557821534manufacture(55526-0001)

Revised: 12/2019
 
EQMAXON Corp.